Using thoracic paravertebral block anesthesia for breast cancer surgery
Thoracic Paravertebral Block Anesthesia for Breast Cancer Surgery: Single-Injection Versus Multiple Injections. A Randomized Controlled Trial
This study is testing whether a single injection of anesthesia in the back can help people having breast cancer surgery feel less pain and have better results compared to the usual method of multiple injections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ciusss de L'Est de l'Île de Montréal Academic / other |
| Locations | 1 site (Montréal, Quebec) |
| Trial ID | NCT05711030 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a single-injection thoracic paravertebral block (TPVB) performed under ultrasound guidance for patients undergoing breast cancer surgery without axillary node dissection. The research compares this method to the traditional approach of using multiple injections for anesthesia. The goal is to determine if the single-injection technique is as effective as multiple injections in managing pain and improving patient outcomes during and after surgery. The study builds on previous findings that suggest TPVB can reduce post-operative complications and enhance patient satisfaction.
Who should consider this trial
Good fit: Ideal candidates for this study are women over 18 years old with ASA status I-III, undergoing partial or total mastectomies without axillary lymph node dissection.
Not a fit: Patients with a BMI over 35, severe cardiovascular disease, or those unable to communicate with investigators may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain management and reduced recovery times for patients undergoing breast cancer surgery.
How similar studies have performed: Previous studies have shown that thoracic paravertebral blocks can effectively reduce post-operative complications, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • Patients \> 18 years old with American Society of Anaesthesiologists (ASA) status I-III, BMI\<35, undergoing partial or total mastectomies without axillary lymph node dissection Exclusion Criteria: * \< 18 years old * Body mass index (BMI) \> 35 * Body weight under 50 kg * Obstructive sleep apnea (moderate to severe) * Unable to communicate with the investigators * Receiving anticoagulation or experiencing any bleeding disorder * Known allergy to local anesthetics, fentanyl or hydromorphone * Active infection at injection sites * Preexisting neurological deficit or psychiatric illness * Severe cardiovascular disease * Liver failure * Renal failure (estimated glomerular filtration rate \<15 mL/ min/1.73 m2) * Pregnancy * Arrhythmia (NOL monitoring cannot be used reliably) * Technical inability to proceed with the blocks * History of chronic pain with daily opioid use during the 3 months before surgery * Patient refusal
Where this trial is running
Montréal, Quebec
- CIUSSS de l'Est de l'Île de Montréal — Montréal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Ariane Clairoux, MD — Ciusss de L'Est de l'Île de Montréal
- Study coordinator: Ariane Clairoux, MD
- Email: ariane.clairoux@umontreal.ca
- Phone: 5142226743
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.